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Oracle Health Sciences IRT On Demand – Service Descriptions

IRT On Demand Services Description

Version 5.5 Effective Date: 24-Jan-2019

This is the IRT On Demand Services Description (“Schedule”) to Your Study Order for Oracle IRT On Demand services. This Schedule described the services provided by Oracle (the “Services”) for the study listed in the Study Order (“Study”). Additional services ordered in Your Study Order (e.g., integration services, etc.) may be described in other schedules. Further details of the Services are shared at the commencement of the Services.


Table of Contents

1.0 OVERVIEW OF SERVICES ................................................................................................. 3

2.0 OPTIONAL SERVICES ....................................................................................................... 3

3.0 DEPLOYMENT AND ENVIRONMENT................................................................................. 3

4.0 USERS AND ACCESS BY USERS ......................................................................................... 3

5.0 DELIVERABLES AND CUSTOMER DEPENDENCIES .............................................................. 4

6.0 ACCEPTANCE OF DELIVERABLES ...................................................................................... 6

7.0 FASTSTART ..................................................................................................................... 6

8.0 FASTFORWARD ............................................................................................................... 9

9.0 FASTLOCK ......................................................................................................................10

10.0 ORACLE CLOUD POLICIES ...............................................................................................11

11.0 APPENDIX ......................................................................................................................12

STUDY SETUP AND MANAGEMENT ............................................................................................... 12

SUBJECT MANAGEMENT ............................................................................................................... 14

RANDOMIZATION .......................................................................................................................... 16

STUDY SUPPLY MANAGEMENT ..................................................................................................... 18

DRUG ACCOUNTABILITY ................................................................................................................ 22

STUDY ADMINISTRATION .............................................................................................................. 23

NOTIFICATIONS AND ALERTS ......................................................................................................... 24

REPORTS ........................................................................................................................................ 25


1.0 Overview of Services

The IRT On Demand Services offering is designed for the use of randomization and trial supply management in the IRT application that uses a secure web browser and phone dial-in to provide access to clinical Study data.

Oracle will provide You with Services for Your Study in three phases: FastStart, FastForward, and FastLock. The activities related to these Services are described below.

During the FastStart phase (“Study Setup”), Oracle provides Services related to project initiation and IRT application set-up to ready the IRT application for User Acceptance Testing (UAT).

During the FastForward phase (“Study Conduct”), Oracle provides Services related to UAT and the management of contracted changes. The FastForward phase starts at the delivery of the IRT application for UAT and concludes upon IRT application lock.

During the FastLock phase (“Study Closure”), Oracle provides Services leading to decommissioning of the IRT application.

Regulatory Compliance: Information on Oracle’s practices for regulatory standards applicable to the handling or processing of data for the Cloud Services or delivery of Trial Build and Configuration Services as described in this Service Description may be viewed at support.oracle.com (Doc ID 2256629.1).

2.0 Optional Services

In addition to the standard Services that Oracle provides to You, optional services are also available, such as:

Drug supply management services – these services may be provided by Services at least every two weeks for Study conduct. Your users have the ability to perform all of these activities in the IRT application without acquiring this service. These activities include manage drug supply types , manage site drug ordering settings, place manual drug order (via the web interface), cancel drug order, manage finished lots and expiry, manage site and depot drug inventory, manage drug label group, associate drug units with finished lots, and associate drug units with drug label groups.

Drug Accountability Software Usage – the drug accountability module can be added to the Study. For further description of the module please see the appendix.

Online Training – online training is available for the duration of the study.

3.0 Deployment and Environment

Your IRT application will be deployed in a hosting facility and will be maintained and managed by Oracle. The deployment of Your environment will consist of two instances: Live and UAT. The Live instance is the instance which will be used to capture the clinical data (“Data”). The UAT instance will be used to perform User Acceptance Testing pre-go-live and will be used to test changes and fixes post-go-live.

4.0 Users and Access by Users

The Services are intended to be used by personnel related to Your Study as authorized by You. Normally this consists of three main groupings of personnel: Sponsor, Site, and Depot. The Sponsor group typically consists of personnel from Your company and may also include other sub-contracted personnel. The Site personnel typically consist of the Site Coordinators (Clinical Research Coordinators) and Study Investigators (Principal Investigators and Sub-Investigators). The Depot group typically consists of personnel from drug supply depots.

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5.0 Deliverables and Customer Dependencies

The deliverables for a given project are dependent upon the components included in that project. Not all projects will produce all of the deliverables listed below. Some common deliverables that apply to most projects include:

Specifications – These are written by the Oracle project team to document the design of the IRT application configurations.

Timeline Planning –This plan will be created and maintained by the Oracle Project Manager. It will outline the key tasks, timelines, and milestones that Oracle and You are responsible for, as applicable.

Communication Plan – This document is created and maintained by Oracle. It describes the team members, their responsibilities, and their contact information.

Study Release for UAT – This is the initial release by Oracle of the configured IRT application in a UAT instance of the production environment to enable Your UAT to be held.

Study Release for Go-Live – This is the live production release by Oracle of the configured IRT application that Your approved end-users may access.

Changes and, Fixes to the Live IRT application – Related documents are created and maintained by Oracle and approved by You.

Help Desk – User support will be accessible via local phone numbers (toll-free where available at Oracle’s discretion).

Maintenance of the Live (Production) environment – Oracle will maintain the production environment in accordance with support services, including product upgrades to new releases (hot fixes, service packs, and minor releases only). Any data migration between versions and upgrades between major product versions will be scoped and contracted separately.

A decommissioning package (i.e. archival study database and associated files related to hosting the Study Production instance including integrations, if any) will be sent to you after Decommissioning.

Archival documentation related to Oracle services (e.g. trial build specifications, change orders, document for trial fix, and service request tickets) will be sent to You via Oracle sFTP periodically during the Services Period.

Your responsibilities for a given project are dependent upon the components included in the project. Examples include but are not limited to:

Delivering clear and complete requirements in accordance with the agreed timeline planning. These may include clinical requirements, phone & web language requirements, and test (dummy) randomization and/or drug schedules. If final requirements are not available, You and Oracle may mutually agree to begin Study design with draft requirements based on a draft protocol. This latter approach may be subject to additional fees.

Providing the final clinical protocol and, as applicable, any subsequent final protocol amendments and ensuring that any required regulatory approvals are in place prior to authorizing Oracle to release the configured IRT Program to Your Production instance. You must also notify Oracle of any technical requirements that result from Your regulatory obligations prior to entering into your order and, if applicable, technical requirements arising from regulatory obligations during the Services Period. Oracle will cooperate with Your efforts to determine whether use of the standard Oracle Services offering is consistent with those requirements. Additional fees may apply to any additional work performed by Oracle or changes to the Services. Any changes to the Services are subject to the Change Management process. You remain solely responsible for Your regulatory


compliance in connect with Your use of the Services. These obligations apply to the initial release and any subsequent releases of the configured IRT Program to Your Production instance that may occur as a result of the Change Management processes.

Providing input into the creation and maintenance of the timeline and milestone planning as requested by the Oracle Project Manager.

Negotiating in good faith an estimated timetable for any revised or additional milestone dates that are introduced after the initial timeline agreement.

Ensuring that all key stakeholders, decision-makers, and team members are present and/or involved with all key meetings and deliverables (e.g. planning and review of the IRT application specifications, user acceptance testing, etc.).

Ensuring that all key stakeholder, decision-makers, and team members adhere to the agreed timelines.

Reviewing draft specifications prior to specification review meetings with Oracle team.

Ensuring specifications meet the regulatory requirements for the Study.

Acceptance of design specifications in a timely manner.

Acceptance of the configured IRT application for release to UAT and for release to go-live.

Testing the UAT environment to Your own standard operating procedures and/or work instructions and for creating and testing Your own test cases. This includes capturing UAT feedback that is clear, reproducible, and actionable in the Oracle provided template. If changes are introduced during UAT, the change management process will be followed (including additional fees and time).

Adding the site and user information directly in the IRT application via an upload utility or directly in the Oracle-provided tool (User Management Tool (UMT)) for studies integrated with InForm™.

Ensuring that all users are properly trained prior to accessing the IRT application. This includes maintaining all training records.

Managing and overseeing third party vendors (e.g. Supply chain management, Central labs, CTMS, external partners, Your subcontractors, etc.). If Oracle will not supply Tier 1 support then You must ensure Your Tier 1 vendor is aware they need to administer Oracle Tier II users.

Reviewing and approving documents related to Live IRT application changes and fixes.

Approving the IRT application database decommissioning and lock.

Reviewing and accepting the following deliverables within sixty (60) calendar days of delivery by returning to Oracle the designated Oracle forms within such acceptance period. If You fail to provide written notice of non-acceptance to Oracle within the acceptance period, as provided above, the deliverables shall be deemed accepted as of the end of the acceptance period and Oracle may permanently delete or otherwise render inaccessible the deliverables and Your Study data in Your instance(s):

o the decommissioning package o relevant archival documentation related to Oracle services

Distributing decommissioning package and archival documentation, as appropriate.

You are responsible for performing the following with respect to User Requirements Specifications: i) Review the User Requirements Specifications (URS) document and confirm that it correctly

identifies all IRT alerts and notifications for Your IRT trial;

ii) Identify the alerts and notifications in the URS that will not be transmitted but will instead be made available for review only within the IRT application. Note the end user will be notified in


email/fax to retrieve the information through the IRT application with a link contained in the body of the email;

iii) Specify the alerts and notifications in the URS that will be transmitted unencrypted (the data will be present in the body of an email or fax); and

iv) Review each alert and notification in the URS and ensure that there is no data contained in any alert or notification that is required under applicable law or regulation to be encrypted during transmission.

You acknowledge and agree that with respect to the alerts and notifications that are transmitted in the URS:

a) and Any alerts or notifications that are sent unencrypted are subject to intercept and access by unauthorized third parties, which creates a security risk for the data contained in the alerts and notifications;

b) You are solely responsible for ensuring that there is no data contained in any alert or notification that is required under applicable law or regulation to be encrypted during transmission; and

c) You are responsible for all damages and liabilities that result from transmitting the data unencrypted.

6.0 Acceptance of Deliverables

Upon completion of any deliverable, Oracle may provide a copy thereof to You. You will be responsible for any additional review and testing of such deliverable in accordance with any mutually agreed review criteria or specifications. If the deliverable does not conform with any such review criteria or specifications, unless stated otherwise in Your obligations above, You shall have five (5) business days after Oracle’s submission of the deliverable (“Acceptance Period”) to give Oracle written notice which shall specify the deficiencies in detail. Oracle shall use reasonable efforts to promptly cure any such deficiencies. After completing such cure, Oracle shall resubmit the deliverable for Your review and testing as set forth above. Upon accepting any deliverable submitted by Oracle, You shall provide Oracle with written acceptance of such deliverable. If You fail to provide written notice of any deficiencies within the Acceptance Period, as provided above, such deliverable shall be deemed accepted at the end of the Acceptance Period. 7.0 FastStart

FastStart consists of activities prior to the availability of the configured IRT Application for User Acceptance Testing (UAT).

Project Management

Oracle Project Manager will:

Create a plan detailing Study tasks and milestones.

Coordinate Oracle project team efforts.

Lead the Study/project Initiation Meeting (PIM).

Track and report Study/project progress.

Change Order initiation, as needed

Work towards signoff of the following major milestones:

o Approval of the Study design specifications.


o Release for User Acceptance Testing (UAT).

Study Design and Build

Oracle will:

• Generate design specifications from Your Study requirements.

• Lead the Specification Review Meeting (SRM) with Your team to review specifications.

• Update specifications based on feedback during SRM for final approval.

• Initiate the change order process (as applicable) if changes to the specifications are made after final approval

• Configure or build Study components as defined in the mutually agreed Study Order and design specifications

o Base set up is up to six treatment arms and up to 10 supply (pack) types.

o Set up of the scheduled visit, replacement visit, unscheduled visit, early termination, completion visit, edit subject data, subject approvals, and subject transfer.

o In addition the following may be setup:

Rescreening of subjects with the option for the subject to keep their original screening/subject number or to receive a new screening/subject number, and the option for including a frequency (one time; multiple times) of re-screenings allowed. This also accounts for any modifications to the standard reports (except for the mapping in case a new screening/subject number is assigned)

Any modification to Date of Birth (DOB) (e.g. only capturing mm-yyyy) will include additional build for modifications needed to other Study parameters, including standard reports that have dependencies on the DOB.

Follow-up visits whether drug dispensing is required or not.

Additional statuses of ‘Discontinuation’ and/or ‘Completion’ of a subject. A ‘Simple’ is defined as only saving the status (either a new status or a modified status) without change status rules nor impact on drug ordering algorithm. A ‘Complex’ is defined with change status rules and/or impact on drug ordering algorithm.

• Set up base web and phone language (English)

• Build translated screens and other relevant text using non-English values.

• Set up randomization (see appendix). Note:

o Emergency un-blinding is setup for all blinded studies.

o Other parameters may be setup:

Central randomization, Blocked randomization, Adaptive design, Stratification, Dynamic stratification, Forced randomization, Cross-over within same Study arm, Cross-over switching Study arm, Cohort, Re-randomization and Replacement randomization

Set up supply management (see appendix). Note:

o Replacement visit for dispensing and unscheduled dispensing visit will be setup for each Study.

o The parameter ‘Do Not Dispense’ (DND) for the Replacement visit is covered as part of Replacement visit setup, if specified.

o Other parameters may be setup:

Bulk non serial (no unique IDs), Bulk & dispensing individual units at sites, Titration (fixed, manual, dynamic), Expected schedule, Run-in/ lead-in dispensing, Forced drug dispensing,


Ability to stop dispensing, Pooling drug supply, Partial dispensing, Multiple depots supplying a site, Resupply of sites (just in time), Resupply of depots (just in time), Calculated treatment dose, DND for unscheduled visit and Drug Accountability (optional services),

o In addition the following may be setup as agreed to in the Study Order:

Non-standard Temperature Excursion: changes to quarantine drug, hold drug until its status is determined, and generate a tracking number for the site and drug supply team.

Non-standard Drug Ordering Form: changes to the standard form. These changes can be adding static text, format change to text, new file format (different from pdf, rtf) or custom form design based on Your template.

Non-standard Investigational Product (IP) Return Form; changes to the standard form. These changes can be only to text and formatting or can be beyond text and formatting changes.

Ability for unblinded pharmacist to dispense medications (i.e; unblinded pharmacist is provided user credentials to access a application report listing treatment arm).

Load one (1) randomization schedule and one (1) drug schedule for setup.

Set up standard reports, ad hoc reporting, notifications, alerts, standard forms (see appendix).Setup non-standard reports and alerts based on the following criteria:

o Non-standard Reports

Re-use – setup of previous customer specific built reports.

Simple: would only contain straight data points

Moderate: would require counts and/or totals

Complex: would require calculations and/or predictions

o Non-standard Alerts

Simple: involve only data entry triggers

Moderate: involve counts and totals

Complex: involve calculations and/or predictions

Set up Study administration (see appendix).

Integrations

Oracle will:

Configure or build integration components as defined in the mutually agreed Study Order and integration specifications, including, as applicable:

o Set up integration with InForm performing the services described in the InForm On Demand Integrations - IRT Services Description document.

o Set up Supply Vendor/Depot, CTMS, and Sponsor/CRO integrations based on these standard parameters:

o File Types:

Text File (txt, rtf) Comma Separated (csv) Excel (xls, xlsx) XML

o Data contained for inbound/outbound files:


By Blinding:

Blinded

Un-blinded

By Type:

Subject data (demographics, randomization, visit records, dispensation records)

Drug data (depot inventory, dispensation, site inventory)

Site data (site details, enrollment summary)

By Volume:

Up to 15 columns per file o Exclusions:

Computed data points (dose formulas, dose/treatment mappings)

o Audit data

Other Services

Oracle will provide these additional services if ordered in the mutually agreed Study Order:

Statistician services

o Provide services for randomization and/ or drug schedules (code lists)

o Provide statistical review/input services of Study setup for central and blocked randomizations (simple); dynamic randomization (aka minimization) and for adaptive design.

Drug supply management services

o Activities related to set up for the Standard services as described in the Optional Services section.

Formal Testing

Oracle will:

Conduct an independent test of Your Study by testing Study components against the mutually agreed specifications.

8.0 FastForward

FastForward consists of activities from availability of the configured IRT application for UAT through confirmation by You of completion of IRT database lock.

Project Management

Oracle will manage the following activities:

One (1) User Acceptance Testing (UAT) findings meeting.

Status meetings (teleconference) at mutually agreed intervals and times

Study scope and initiation of Change Orders, as needed.

Meetings to discuss deliverables of Change Orders, as needed.


User Acceptance Testing

Oracle will:

Assess and address questions that You find in UAT that are directly related to the mutually agreed Study requirements.

If required, deploy the new build to the UAT environment for You to re-test Your findings

Help Desk

Oracle will:

Provide Help Desk support via local phone numbers (toll-free where available at Oracle’s discretion).

Escalate calls to You, as appropriate.

Other Services

Oracle will provide the following services if ordered in the mutually agreed Study Order:

Statistician services as defined for Fast Start

Standard drug supply management services

UAT services

o UAT scripts

Simple: randomization only studies Moderate: randomization plus multiple drug assignments Complex: cohort, adaptive designs, complex drug management.

o Loading UAT data to cover up to complex UAT scripts.

Data Requests

o The data contains information about subjects, visits, and drugs dispensed. o Audit trail information is not included. o Delivery provided in ACSII, SAS data sets, or XML format.

o Types:

Simple: request would only contain straight data points Moderate: request would require counts and/or totals Complex: request would require calculations and/or predictions

Additional Randomization and/or Drug Schedule Loads

9.0 FastLock

FastLock services consist of those relating to the management of the production environment from confirmation by You of completion of IRT Database Lock to Study Decommission.

Project Management

Oracle will:

Liaise with Your team for activities needed to close out the Study

Provide a final data extract. The standard data extract delivery is as follows:


o The data extract contains the data about subjects, visits, and drugs dispensed.

o Audit trail information is included.

o Delivery provided in PDF or XML format.

Help Desk

Oracle will:

Terminate user accounts.

Study Hosting and Application Management

Oracle will:

Decommission and recycle the Study environment.

10.0 Oracle Cloud Policies

The Services are subject to the Oracle Cloud Hosting and Delivery Policies document, which is part of the Service Specifications of Your order and may be viewed at www.oracle.com/contracts.

10.1. Disaster Recovery Specifications

The Recovery Time Objective (RTO) is 90 days.

The Recovery Point Objective (RPO) is 48 hours.

10.2. Target Application Availability Level

The Target Application Availability Level is ninety-nine percent (99%).

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11.0 APPENDIX

IRT 5.5 Product Functionality

This Appendix to the Services Description is a description of the IRT application functionality. This Appendix does not describe the Services that Oracle will perform, but describes only the available features of the IRT application. Oracle will only perform the Services described in the body of the Services Description.

The following functions are phone and web: Screening, Screen Fail, Randomize, Scheduled Visit, Study Supply Replacement, Early Terminate, Completion, Unblind Treatment, Register Site/Depot Order Receipt, and Update Site/Depot Inventory. All other functions are web-only.

STUDY SETUP AND MANAGEMENT

Screening/ Enrollment

Provide ability to register a subject as screened and verifies the parameters are met prior to allowing transaction to continue:

o Study, Region, Country, and Site are open for Screening

o The Study, Region, Country, and Site Screening limits have not been met

o The Study, Region, Country, and Site Randomization limits have not been met

Capture the following subject demographic information, including any combination of:

o Date of Birth (Day, month, and year)

o Initials (Application provides option for automatic initial assignment based on country.)

o Gender

Capture the screening date in one of the following ways:

o Uses the current date.

o User enters the screening date.

Assign the Subject Number in one of the following ways:

o Assigns the subject number by concatenating the site number with a sequential number.

o Assigns the subject number sequentially by Study

o User enters the subject number

Note: This function will not be available when the site is closed.

Screen Fail

Provide ability to register a subject as screened failed, requests the input of subject number and verifies subject number prior to allowing transaction to continue.

Request user to verify demographic information prior to allowing transaction to continue.

Capture a set of pre-defined screen fail reasons.

Capture the screen fail date by using the current date or via user entry of the screen fail date.



Scheduled Visit

Provide the capability to register a visit with a Study supply assignment. Verifies all Study supply types for Study supply assignment are available; if not, verifies whether there is a supply order in-transit to the site.

o If there is an order in transit, the IRT application will notify the user. o If supplies are not available, the transaction will not continue.

Request the input of subject number and verifies subject number prior to allowing transaction to continue.

Request and verify demographic information prior to allowing transaction to continue.

Determine the visit and verify the visit is the correct one prior to allowing transaction to continue.

Verify the visit is taking place within the proper visit window prior to allowing transaction to continue (hard stop).

Out of Window Approval:

o When Out of Window Approval is implemented and approval was granted, the user will be allowed to proceed to process a scheduled visit for a subject who is not within the acceptable visit window.

Verify the visit is taking place within the proper visit window. The IRT application requires user confirmation prior to allowing transaction to continue (soft stop).

Verify there are Study supplies available at the site for the required treatment prior to allowing transaction to continue.

Assign the appropriate Study supplies to the subject.

Repeat the Study supply dispensing information (phone).


Study Supply Replacement

Provide the capability to replace dispensed serialized Study supplies and verifies all Study supply types for randomization are available; if not, IRT application verifies whether there is a supply order in-transit to the site.



Verify the subject has been randomized and has not been early terminated or completed prior to allowing transaction to continue.


Determine the visit and verify the visit is the correct one prior to allowing transaction to continue.

Request the input of a Study supply unit number and verifies the unit was dispensed during the last visit and has not already been entered during the current transaction prior to allowing transaction to continue.

Request the input of the supply unit status.

Request additional input of Study supply unit numbers and status until user confirms everything has been entered.


Verify there are Study supplies available at the site for the required treatment prior to allowing transaction to continue.

Assign the appropriate Study supplies to the subject.

Assign Study supplies to the subject by replacing the damaged/missing units; IRT application can repeat information on the phone.


Early Termination

Provide the capability to register a subject as early terminated. IRT application requests the input of subject number and verifies subject number prior to allowing transaction to continue

Verify the subject has been randomized and not already early terminated prior to allowing transaction to continue.


Capture a set of pre-defined early termination reasons.

Capture the early termination date by using the current date or via user entry of the screen fail date.

Verify the early termination date is valid prior to allowing transaction to continue.

Update subject status to Early Terminated.


Completion

Provide the capability to complete subjects, request the input of subject number and verify subject number prior to allowing transaction to continue.

Verify the subject has been randomized, completed all scheduled visits, and has not been early terminated or completed prior to allowing transaction to continue.


Capture a set of pre-defined early termination reasons.

Capture the completion date by using the current date or via user entry of the screen fail date.

Verify the completion date is valid prior to allowing transaction to continue. Note: This function will not be available when the site is closed.

SUBJECT MANAGEMENT

Edit subject data

Provide the capability to modify subject data points.

User may modify the following subject data points:

o Initials o Date of Birth o Gender


o Transaction Date o Screen Fail Reason o Early Termination Reason

User may modify and/or delete subject data points: o Screen Fail Date o Early Termination date

User may modify and/or roll back subject data points/visits. The roll back of the status of the associated dispensed drug is available (if applicable). All roll back transactions are configurable with up to two levels of approval per design:

o Screen fail entry o Randomization entry o Scheduled visit o Drug replacement visit o Early termination visit o Completion visit

Requires the entry of a reason for change prior to saving data.

Not allow initials to be edited (initials will be grayed-out) when initials are automatically assigned by the IRT application based on country requirements. Will allow for this function to be available or unavailable when the site is closed.

Subject Approvals

The application can automatically send an Age Approval request to the appropriate sponsor, when the subject’s age falls outside the study limits, based on the date of birth entered during the screening transaction.

The application shall allow a user to request a preapproval for a future visit when it is known that the subject requires the visit to occur outside the pre-defined visit window.

Request the selection of the type of approval.

Request the selection of site number.

Request the selection of subject number.


For Out of Window Visit Approvals, request the selection of the visits.

Request user to confirm approval.

Subject Transfer

Provide the capability to transfer subjects between sites.

Request the selection of the original site.

Request the selection of subject.

Request the selection of the new site.


Subject Flag

The application shall allow authorized users to flag subjects as either Mis-Randomized or Off-Treatment. The application shall display a flag icon next to the subject number for the flagged subject in the subject transactions grid, which is visible only to the authorized users.

RANDOMIZATION

Randomization – Design

The following are some descriptions of randomization designs done in the IRT application:

Central – selects the next subsequent treatment from a central list.

Central + Stratified – selects the next subsequent treatment based on strata.

Country Blocked Dynamic – dynamically allocates a block to a country and selects the next subsequent treatment from that block. If and when a block has been exhausted by a country, IRT application will accordingly allocate the next available block.

Country Blocked Dynamic + Stratified – dynamically allocates a block to a country based on strata and selects the next subsequent treatment from that block. If and when a block has been exhausted by a country, IRT application will accordingly allocate the next available block.

Country Blocked Fixed – selects the next subsequent treatment from a pre-defined list of blocks by country.

Country Blocked Fixed + Stratified – allocates a pre-defined block based on strata to a country and selects the next subsequent treatment from that block.

Site Blocked Dynamic – dynamically allocates a block to a site and selects the next subsequent treatment from that block. If and when a block has been exhausted by a site, IRT application will accordingly allocate the next available block.

Site Blocked Dynamic + Stratified – dynamically allocates a block to a site based on strata and selects the next subsequent treatment from that block. If and when a block has been exhausted by a site, IRT application will accordingly allocate the next available block.

Site Blocked Fixed – allocates pre-defined block to a site and selects the next subsequent treatment from that block.

Site Blocked Fixed + Stratified – allocates a pre-defined block based on strata to a site and selects the next subsequent treatment from that block.

Forced Randomization may be an additional parameter to any of the above methods. The IRT application will move to the next treatment/randomization number for which there is Study supply available when the Study supply units for the assigned treatment are not available. When there are blocks, the IRT application may require allocating a new block if the current block does not contain any available treatments.

o When forced randomization is implemented, the IRT application back-assigns unused randomization numbers to new subjects as they are randomized.

Note: Fixed and dynamic refers to how the blocks are assigned. Fixed blocks are pre-assigned per the randomization schedule; dynamic blocks are assigned in the order the subjects are randomized by country or site, pending the Study randomization method.


Randomization

Provide the capability to register a subject as randomized. IRT application verifies the applicable parameters are acceptable prior to allowing transaction to continue:

o Study, Region, Country, and Site are open for randomization o The Study, Region, Country, and Site randomization limits have not been met

Verify all Study supply types for randomization are available; if not, IRT application verifies whether there is a supply order in-transit to the site.




Verify the subject number is valid for the site, and that the subject is within the acceptable age range prior to allowing user to proceed.

Age Approval:

o When Age Approval is implemented and approval was granted, the user will be allowed to proceed to randomize a subject who is not within the acceptable age range.

Verify the randomization is taking place within the proper visit window prior to allowing transaction to continue.

Out of Window Approval:

o When Out of Window Approval is implemented and approval was granted, the user will be allowed to proceed to randomize a subject who is not within the acceptable visit window.

Verify the Study supply type determined by the randomization algorithm is available prior to allowing transaction to continue.

If forced randomization is implemented, IRT application shall verify there are Study supply types available at the site for any randomization treatment:

o If any type is available, the transaction will continue. o If Study supplies are not available, then the transaction will not continue, if forced

randomization is not implemented.

Assign the next available (sequential) randomization number to the subject based on approved randomization list.

When forced randomization is implemented, subject shall be assigned the next available (non-sequential) treatment on the approved randomization list.

Assign the appropriate Study supplies to the subject based on the treatment assigned,

Display or read out randomization number; IRT application can repeat the randomization and Study supply dispensing information on the phone.


Randomization Schedule

Allow user to view, export, and approve the randomization schedule. Approval of the schedule requires an electronic signature.


Allow user to see a history of approval(s).

Emergency Break-blind / Unblind Treatment

Will provide the capability to unblind the treatment of a subject. The IRT application requests the input of site number and verifies site number prior to allowing transaction to continue for non-site users performing unblinding.

Provide warning about unblinding and verifies the user would like to proceed with the unblinding.



Verify the subject has been randomized prior to allowing transaction to continue

Request user verification to continue with unblinding transaction.

Provide ability to request user to input password.

Display or read out the current randomization treatment arm; IRT application can repeat the treatment information on the phone.

Allow for repeatedly unblinding of subjects.

Will discontinue/not discontinue the subject depending on the role who performed the unblinding.

Allow for one-time use unblinding User IDs (User ID will only be valid for one unblinding transaction).

Allow for this function to be available or unavailable when the site is closed.

STUDY SUPPLY MANAGEMENT

Ordering – General Information

Quantity based on visit schedule

o Predictive Resupply

o Generates re-supply shipments to sites based on inventory levels and subjects’ expected visits. Designated users may create a re-supply type to control projection windows and buffer quantities.

o Quantity based on site-blocked look ahead

o Buffer-Triggered Resupply

o Generates subsequent re-supply for sites based on site inventory and fixed re-supply quantities (Min and Max values).

o Single unit ordering

o Has capability to restrict single Study supply unit ordering for specified Study supply type(s).

o Automatically picks a random Study supply unit if single Study supply unit ordering is restricted for a Study supply type.

o Supply order schedule

o Has capability to run automatic ordering on a defined schedule.

o Has capability to run manual ordering on a defined schedule.

o Supply order outputs

o Generates Study supply ordering forms in one or more of the following formats: Rich Text Format (*.RTF), Adobe Acrobat (*.PDF), Excel (*.xls), and bar codes.


o Supply Pooling

o When two or more IRT applications share a pooled supply, the shared supply is available to all IRT applications sharing the units, e.g., units are displayed in all Study supply-related functions for all IRT applications.

o When IRT applications are configured to have Study supply pooling, Study supply ordering for each Study selects units from the shared pool of units. Once a Study supply unit is selected for a specified IRT application, that unit is associated with only that specified IRT application and does not appear in any of the other IRT applications.

Predictive ordering Methodology

o When automatic Study supply ordering runs for sites, the IRT application orders Study supply quantities based on the predictive method detailed below (see Diagram below) and the configured re-supply configuration associated to that site.

o When ordering Study supplies by Study supply type, the IRT application selects from the earliest expiring finished lot (lot expiration date – DNS days > day shipment ordering runs) and pick units in ascending sequence number.

o When ordering Study supplies manually by sequence number, the IRT application selects units based on the sequence number.

o Allow configuration of re-supply triggering for individual Study supply types, i.e., triggering ordering for one Study supply type will not necessarily trigger ordering for ALL Study supply types. This will be based on the re-supply grouping(s).

o Is configurable to allow for initial automatic Study supply ordering to be triggered based on initial site activation or 1st subject screened.

TOTAL QUANTITY NEEDED (TQN)calculate amount required within

(RW) for all subjectsADD: (MaxB)

SUBTRACT: (SAI)

SITE AVAILABLE INVENTORY (SAI)amount available at siteADD: number in-transit

SUBTRACT: number with DNC (expiry)

PROJECTED NEED (PN)calculate amount required within (TW) for all subjects

ADD: (MinB)

(PN) > (SAI) Yes

No

No calculations / No drug order

Drug Order = (TQN)

Trigger Weeks (TW)

Re-Supply Weeks (RW)

Minimum Buffer (MinB)Maximum Buffer (MaxB)

o When Label Groups are utilized and ordering is done for a site, the IRT application shall select Study supply units as follows:

Only picks Study supplies within the label group to which the site country is associated.

Picks from all label groups the site is associated to by lot expiration date, DNS date, and then by Sequence ID.

o When Label Groups are utilized and ordering is done by quantity for a depot, the IRT application selects Study supply units as follows:

Only picks Study supplies within the label group to which the destination depot supplies.


Picks from all label groups by lot expiration date, DNS date, and then by Sequence ID, if ordering is done by Study supply type.

Picks from all label groups by Sequence ID, if ordering is done by sequence number.

o When Label Groups are utilized and ordering is done by sequence number for a depot, the IRT application shall select Study supply units as follows:

Only picks Study supplies within the label group to which the country is associated.

Picks from all label groups by lot expiration date, DNS date, and then by Sequence ID.

SMART application

Allow user to set up threshold days to calculate potential Study supply stock-out induced by a sudden increase in enrolment.

Send alerts when there is potential stock-out, and has the capability to automatically create manual orders based on the need induced by the sudden increase in enrolment.

Depots

Allow users to set up new supply and return depots in the IRT application.

Allow user to input and edit depot information, depot settings, and depot inventory alert triggers.

Depot Association

o IRT application allows users to associate and disassociate Study supply units to depots.

Lots and Expiry

Allow users to add and edit finished lot numbers and associated information, including lot number, run number, lot parameters, expiration date, and manufacturing lots number(s).

Allow user to repeatedly update the lot expiry date, regardless of location, and displays a history of each entry.

Allow user to over-label all unused Study supply units associated to each lot.

Allow user to take change the lot status (In Use/Not in Use) with electronic signature confirmation.

Manufacturing lots o Allow users to set add and edit manufacturing lot numbers and associated information.

Lot Association o Allow users to associate and disassociate Study supply units to finished lots.

Label groups

Allow user to create label groups with countries in the IRT application.

Label group Association o Allow users to associate and disassociate Study supply units to label groups.

Resupply Setting

Allow users to set up multiple Study supply strategies. IRT application requests the input of resupply name, trigger weeks, resupply weeks, min buffer, max buffer, and initial supply.

Allow user to edit Study supply strategies and to delete strategies not associated to any sites.

Inventory Management

Allow user to update the status of Study supply units at sites and depots. The statuses applied will be determined by the Study design.


Register Site Supply Order Receipt

Provide the capability to register an order as received by site. IRT application requests the supply order number and verifies it’s valid for the site.

Request user to confirm if the entire order arrived complete and intact. The IRT application updates the units within the order with the applicable status.

Request user to input individual units and unit status if individual units were impacted.

Update the units with the applicable status.

Register Depot Supply Order Receipt

Provide the capability to register an order as received by depot. IRT application requests the supply order number and verifies it’s valid for the depot.

Request user to confirm if the entire order arrived complete and intact. The IRT application updates the units within the order with the applicable status.



Verify that there are supplies at the site prior to allowing user to continue.

Request user whether the entire inventory is damaged or has incurred a temperature excursion.

Update the inventory with the applicable status.



Update Site/Depot inventory

Provide the capability to change Study supply statuses. IRT application verifies that there are supplies at the site/depot prior to allowing user to continue.

Request user whether the entire inventory is damaged or has incurred a temperature excursion.

Update the inventory with the applicable status.



Shipment Information

Allow user to enter shipment information for a Study supply order, including the courier name, tracking number, and ship date.

Cancel Order

The cancellation of a drug order is performed in two steps: the initiation and the completion. Depending on the 'applications’ configuration the permissions to access these two steps can be granted to different roles in order to provide the process flow to confirm the shipment has not left the depot. .

Once the user initiates the drug order cancellation, the drug order will be displayed as having the status ‘Cancel Requested’.

The application updates the order as cancelled upon completion of the drug order cancellation; the units in the order are placed back at the applicable depots for subsequent shipments.


Request Manual Order

Allow user to request a manual Study supply order.

Request user to select the source and destination.

User may request units by quantity for sites, and by quantity or sequence for depots.

Site Ordering Management

Allow user to manage the site ordering status.

User has the ability to associate a resupply strategy to each site.

User has the ability to repeatedly open and close site drug ordering.

Allow user to suspend Study supply ordering for a specified site.

Allow user to remove Study supply ordering suspension for a specified site.

Drug Schedule

Allow user to export and approve the randomization schedule. Approval of the schedule requires an electronic signature.

Allow user to see a history of approval(s).

DRUG ACCOUNTABILITY

Reconciliation by site and monitor

Site user functionality.

o Allow site user to initiate the drug reconciliation process.

o Request the selection of units and input of drug reconciliation for each unit, including quantity dosed, quantity unused/damage, quantity lost/missing, and reconciliation date. User may also optionally enter comments.

o Allow user to update information until units have been reconciled by the monitor.

Monitor user functionality.

o Allow monitor user to confirm the quantities entered by the site user by entering a reconciliation date. User may also optionally enter comments.

o Allow monitor user to reject the quantities entered by the site user.

Ready for Shipment or destruction or shipment

The IRT application:

Allow the user to select the method of destruction.

Generate a Destruction ID when the method is site destruction.

Request the user to enter the shipping information when the method is return depot.

Require electronic signatures from the monitor and site users prior to completing the transaction. The electronic signature capture is contemporaneous when the drug is considered a controlled substance.

Allow user to entering a new value when there is a discrepancy entered by the return depot user.


Reconciliation by Return Depot

Allow the return depot user to register the status of the return shipment, whether 100% verification was conducted, the shipment receipt date, and the quantities received.

Allow the return depot user to register units as being processed for destruction once all units have been properly reconciled.

STUDY ADMINISTRATION

Study Management

Country Management

o Allow user to add countries to the Study.

Region Management

o Allow user to create regions to the Study.

Study limit management

Provide capability to manage screening/randomization at the Study, region, and country levels in the following ways:

o Open and close screening/randomization. o Repeatedly set and modify screening/randomization limits at each level.

Limits are applied in the following order: Study, Region, Country, and Site, where applicable.

Display the current number of subjects screened, randomized, screen failed, early terminated, and completed at the Study, Region, and Country levels.

Role Notifications

Provide capacity to manage distribution of notifications based on role.

Allow user to select or deselect notifications that be received by a specified role.

Use the selections in this function in conjunction with selections from the User Link to Sites & Depots function:

o Once a user is linked, the user will only receive notifications selected.

Notifications

Allow user to view and re-transmit notifications.

Study Specific Reference Material

Provide capacity to display reference materials.

Items listed in this section shall be based on the Manage Custom Menu Items function.

Site Management

Sites

o Allow user to add and edit sites and site information.

o Allow user to activate and deactivate sites.

o User can open and close Screening and Randomization for each site.

o User can set and modify Screening and Randomization limits for each site.


Sites Upload

o Allow users to download a spreadsheet formatted for uploading site information.

o Allow user to upload multiple records at once into the IRT application after user enters the correct password.

o Allow user to correct erroneous data prior to committing the information.

User management

Edit User o Allow users to update contact information for other users in the IRT application.

Link to Site/Depot o Allow users to link non-site and non-depot users to sites and/or depots.

User upload

Allow users to download a blank spreadsheet formatted for uploading user information.

Allow user to upload multiple records at once into the IRT application after user enters the correct password.

Allow user to correct erroneous data prior to committing the information.

Pending users o Allow users to update information for users who have not yet been authenticated.

o Allow user to disable/en-able users and to re-transmit new User Authentication Forms.

NOTIFICATIONS AND ALERTS

The IRT application can be configured to send notifications and alerts to application users upon completion of a transaction or to alert for pending events. As noted above in Section 5.0, you are responsible for ensuring that you choose the appropriate delivery mechanism for notifications and alerts based on the sensitivity of the data elements they contain. The end user has the ability to print and download alerts, notifications, and reports such as drug order forms from the application.

The IRT application supports the following notifications:

Web and Phone Confirmations

o Screening Confirmation o First Subject Screening Confirmation o Screen Fail Confirmation o First Subject Screen Fail Confirmation o Randomization Confirmation o First Subject Randomization Confirmation o Scheduled Visit Confirmation o Study Supply Replacement Confirmation o Additional Study Supply Assignment Confirmation o Early Termination Confirmation o Completion Confirmation o Unblind Treatment Confirmation (Blinded) o Unblind Treatment Confirmation (Unblinded) o Study Supply Order Receipt Confirmation o Site/Depot Inventory Update Confirmation


Web-Only Confirmations

o Edit Subject Data Confirmation o Age Approval Confirmation o Out of Window Approval Confirmation o Initial Site Activation Confirmation o Cancel Order o Site / Depot Inventory Update Confirmation o Study Supply Reconciliation (Ready for Destruction) Confirmation o Ship Information

The following standard alerts are available:

Randomization or Screen Fail Alert

Subject Late Visit Alert

Overall Study Limit Alert

Overdue Study Supply Order Alert

Partial Study Supply Order Alert

Failed Study Supply Order Alert

Low Depot Alert (Unblinded)

Low Depot Alert (Blinded)

Lot Expiration Alert

Quarantined Study Supply Summary Alert

Overdue Depot Shipment Alert

Study Supply Reconciliation (Site and Monitor) Alert to Monitor

Study supply Reconciliation (Site and Monitor) Alert to Site

Study supply Reconciliation (Ready for Shipment) Alert to DDF

Study supply Reconciliation (DDF) Alert to Monitor

Site Potential Stock-Out Alert

Study User ID Access

The following standard forms are available, if applicable:

Blinded Shipment Order Form

Unblinded Shipment Order Form

User Authentication Form

Password Reset Form

IP Return Form

REPORTS

The IRT application supports the following reports:

Subject

o Subject Summary (Blinded and Unblinded)

o Subject Visit Summary

o Randomization Report (Unblinded)

Study

o Enrollment Summary

o Site Overall & Monthly Summaries

o Study Overall & Monthly Summaries


o Site Statistics

o Site Audit

Supplies

o Order Summary

o Site Inventory (Blinded and Unblinded)

o Depot Inventory (Blinded and Unblinded)

Detailed Site & Depot Inventory (Blinded and Unblinded)

Drug Accountability Overview

o Detailed Study Supply Reconciliation

o Study Projected Supply Usage

Users

o User Contact Information

o Application Access

Ad hoc reporting

User can create, save, and share unlimited real-time ad-hoc reports using an intuitive user interface to query any data point collected by the IRT application.

Generate new reports

o Allow user to select applicable fields.

o Generate a custom report based on selection of data fields and conditions.

o Allow user to save the report.

o Provide capacity to share reports with other users and roles.

o Allow user to export the report in the following formats:

ASCII delimited by comma Excel PDF

Save, view, and share reports

o Provide capacity to display reports saved by the user, or reports shared with the user.

o Provide capacity to share reports with other users and roles:

Unblinded users cannot share unblinded reports with blinded users.

Display report attributes, including, the Title, Description, Created (date), Created By, Last Run (date), and Status.

Ability to repeatedly regenerate the report.

Ability to modify the Title, Description, and sharing rights.

Ability to delete the report.

User shall have view-only permission to reports shared by other users.

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